Extreme or morbid obesity is a serious medical condition pervasive in the United States and other countries. Its complications include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems and pulmonary insufficiency with markedly decreased life expectancy.
Several surgical techniques have been developed to treat morbid obesity, e.g., bypassing an absorptive surface of the small intestine, or reducing the stomach size. These procedures are difficult to perform in morbidly obese patients and present numerous life-threatening post-operative complications.
U.S. Pat. Nos. 4,416,267 and 4,485,805 to Garren et al. and Foster, Jr., respectively, propose disposal of an inflated bag within a patient's stomach to decrease the effective volume of the stomach that is available to store food. Accordingly, the patient is satiated without having to consume a large amount of food. A common problem with these inflated bags is that, since the bags float freely within the patient's stomach, the bags may migrate to and block a patient's pyloric opening, the portal leading from the stomach to the duodenum, thereby restricting passage of food to the remainder of the gastro-intestinal tract.
Apparatus and methods also are known in which an adjustable elongated gastric band is disposed around the outside of a patient's stomach near the esophagus to form a collar that, when tightened, squeezes the stomach into an hourglass shape that limits the amount of food that a patient comfortably may consume. An example of an adjustable gastric band is the LAP-BAND® made by INAMED Health of Santa Barbara, Calif.
Numerous disadvantages are associated with using the adjustable gastric band. First, the band may be dislodged if the patient grossly overeats, thereby requiring additional invasive surgery to either reposition or remove the band. Similarly, overeating may cause the band to injure the stomach wall if the stomach over-expands. The laparoscopic disposal of the gastric band around the stomach requires a complex procedure, requires considerable skill on the part of the clinician, and is not free of dangerous complications. To dispose the gastric band around a patient's stomach, a clinician must perform a surgical procedure to gain access to the patient's stomach from outside the stomach. This is typically performed using the narrow field of vision provided by a conventional laparoscope, and presents a risk that the clinician inadvertently may perforate the stomach, damage major organs and vessels disposed in the vicinity of the stomach, such as the liver, kidneys, and the abdominal aorta, damage the vagus nerve and/or cause numerous other complications associated with surgery.
In view of the foregoing, it would be desirable to provide apparatus and methods for partitioning a GI lumen by intraluminally reducing a local cross-sectional area thereof.
It also would be desirable to provide apparatus and methods for partitioning a GI lumen without substantially altering a native shape of the lumen.
It further would be desirable to provide apparatus for partitioning a GI lumen that decreases the risk that the apparatus may become dislodged.
It still further would be desirable to provide apparatus for partitioning a GI lumen that is easy to deliver.
It even further would be desirable to provide apparatus and methods for partitioning a GI lumen that reduces the risk of damage to surrounding organs, vessels, and nerves.
It also would be desirable to provide apparatus and methods for partitioning a GI lumen, in which a cross-sectional area of a partition defined by the apparatus may be endoscopically adjusted.
It additionally would be desirable to provide apparatus and methods for partitioning a GI lumen, in which a cross-sectional area of a partition defined by the apparatus may be dynamically adjusted responsive to the pressure of food proximal to the apparatus.
It also would be desirable to provide apparatus and methods for partitioning a GI lumen, in which a cross-sectional area of a partition defined by the apparatus may be remotely adjusted via wireless communication with an external control unit.